Status:
COMPLETED
Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Cognitive Dysfunction
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief Summary
Postoperative cognitive impairment develops in the early and continues in the late postoperative period; it is manifested by impaired memory, attention, concentration and other higher cortical functio...
Detailed Description
Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves coronary and cerebral blood flow, activates metabolic processes in the central nervous system, r...
Eligibility Criteria
Inclusion
- Signed informed consent
- Men and women aged 60-80 years, inclusive.
- Planned cardiac surgery, which does not assume the use of a cardiopulmonary bypass.
- Planned or delayed orthopedic surgery (hip joint endoprosthetics, osteosynthesis for fractures of the proximal third of the hip, etc.), under general or combined anesthesia.
- Legal capacity of the patient
- Absence of dementia (MoCA≥17, MMSE≥19)
- Lack of reproductive potential or
- Consent to use adequate methods of contraception
Exclusion
- Hypersensitivity to any component of the study drug
- Emergency surgery
- Repeated surgery or reoperation
- Anesthesia risk ASA≥5
- Severe visual or hearing impairment which impedes the performance of neuropsychological tests
- Operation under general anesthesia in the previous 3 months
- Severe renal failure requiring replacement of renal function (dialysis)
- Severe hepatic failure (class C and above in Child-Pugh)
- Chronic obstructive pulmonary disease
- Terminal stage of other chronic incurable diseases
- Decompensated diabetes
- A history of oncological diseases, mental illness, HIV infection, syphilis, tuberculosis, alcohol or drug addiction
- The use of 5 or more units of alcohol per week in the previous 3 months
- Diagnosis of mental or neurodegenerative disease (e.g. schizophrenia, Parkinson's disease, clinically manifest depression)
- Permanent intake of psychotropic drugs (neuroleptics, tranquilizers, antidepressants)
- Course intake of nootropic drugs in the previous 3 months
- Communicative, sensory, motor, or any other deficiency that does not allow the patient to adequately assess their behavior and correctly fulfill the conditions of the study protocol.
- The presence in the history of any significant, according to the physician-researcher, condition that prevents the inclusion of the patient in the study.
- Participation in any clinical study in the previous 3 months
- Employees of the study centres and their family members.
Key Trial Info
Start Date :
June 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03849664
Start Date
June 2 2017
End Date
July 11 2019
Last Update
January 31 2023
Active Locations (13)
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1
Regional Clinical Hospital № 3
Chelyabinsk, Russia
2
Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation
Moscow, Russia
3
Alexandrovskaya City Hospital
Saint Petersburg, Russia
4
City Hospital №15
Saint Petersburg, Russia